Data Foundry

Drug recalls 2022

PAIN AID ESF- — Class II drug recall D-0327-2022

Terminated recall by ULTRAtab Laboratories, Inc., reported 2022-01-12. CGMP Deviations: failed stability results, inadequate laboratory investigations,

Recall numberD-0327-2022
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmULTRAtab Laboratories, Inc., Highland, NY, United States
Recall initiated2021-11-29
Classified2022-01-04
Reported by FDA2022-01-12
Terminated2023-02-24
Reason classescgmp, specification failure
NDC62959-0560-00
Lot numbers18K070, 19A046, 19C073, 19E014, 19G039, 19K002, 20A013, 20B050, 20C011, 20C049, 20F071, 20F072, 20G033, 20G041, FEB-23, JAN-22, JAN-23, JUL-22, JUL-23, JUN-23, MAR-22, MAR-23, MAY-22, NOV-21, NOV-22

Product

PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L

Reason for recall

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0327-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.